Long Term Use of Somatropin in Patients Small for Gestational Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00793325
First received: November 17, 2008
Last updated: December 17, 2013
Last verified: December 2013
Results First Received: December 17, 2013  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Small for Gestational Age
Intervention: Drug: Somatropin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Somatropin for Small-for-gestational Age Participants taking somatropin for small-for-gestational age according to Japanese package insert.

Participant Flow:   Overall Study
    Somatropin for Small-for-gestational Age  
STARTED     909  
COMPLETED     890  
NOT COMPLETED     19  
Protocol Violation                 18  
Lost to Follow-up                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Somatropin for Small-for-gestational Age Participants taking somatropin for small-for-gestational age according to Japanese package insert.

Baseline Measures
    Somatropin for Small-for-gestational Age  
Number of Participants  
[units: participants]
  890  
Age, Customized  
[units: participants]
 
<15 years     884  
>=15 years     6  
Gender  
[units: participants]
 
Female     423  
Male     467  



  Outcome Measures
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1.  Primary:   Number of Participants With Treatment Related Adverse Events.   [ Time Frame: Up to 3 years ]

2.  Primary:   Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.   [ Time Frame: Up to 3 years ]

3.  Primary:   Number of Participants With Treatment Related Adverse Events of Somatropin: <15 Years of Age vs. >=15 Years of Age.   [ Time Frame: Up to 3 years ]

4.  Primary:   Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.   [ Time Frame: Up to 3 years ]

5.  Primary:   Number of Participants With Treatment Related Adverse Events of Somatropin Based on SGA Severity.   [ Time Frame: Up to 3 years ]

6.  Primary:   Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.   [ Time Frame: Up to 3 years ]

7.  Primary:   Number of Participants With Treatment Related Adverse Events of Somatropin: With Complications vs. Without Complications   [ Time Frame: Up to 3 years ]

8.  Primary:   Number of Participants With Treatment Related Adverse Events of Somatropin: With Hepatic Function Disorder vs. Without Hepatic Function Disorder.   [ Time Frame: Up to 3 years ]

9.  Primary:   Number of Participants With Treatment Related Adverse Events of Somatropin: With Renal Impairment vs. Without Renal Impairment.   [ Time Frame: Up to 3 years ]

10.  Primary:   Number of Participants With Treatment Related Adverse Events of Somatropin: With Concomitant Drug(s) vs. Without Concomitant Drug(s).   [ Time Frame: Up to 3 years ]

11.  Primary:   Change in the Growth Rate Standard Deviation (SD) Score for Calendar Age.   [ Time Frame: Up to 3 years ]

12.  Primary:   Change in Height SD Score for Calendar Age.   [ Time Frame: Up to 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00793325     History of Changes
Other Study ID Numbers: A6281292
Study First Received: November 17, 2008
Results First Received: December 17, 2013
Last Updated: December 17, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency (PMDA)